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Full Prescribing Information for Prolong Aptt for up to 120 Hours, and May Prolong PT and INR for up ORBACTIV

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Full Prescribing Information for Prolong Aptt for up to 120 Hours, and May Prolong PT and INR for up ORBACTIV HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------WARNINGS AND PRECAUTIONS----------------------- These highlights do not include all the information needed to use • Coagulation test interference: ORBACTIV has been shown to artificially ORBACTIV safely and effectively. See full prescribing information for prolong aPTT for up to 120 hours, and may prolong PT and INR for up ORBACTIV. to 12 hours and ACT for up to 24 hours. For patients who require aPTT monitoring within 120 hours of ORBACTIV dosing, consider a ORBACTIV® (oritavancin) for injection, for intravenous use non-phospholipid dependent coagulation test such as a Factor Xa Initial U.S. Approval: 2014 (chromogenic) assay or an alternative anticoagulant not requiring aPTT. (5.1, 7.2) ----------------------------INDICATIONS AND USAGE--------------------------- • Serious hypersensitivity reactions, including anaphylaxis, have been ORBACTIV is a lipoglycopeptide antibacterial drug indicated for the reported with the use of oritavancin products, including ORBACTIV. treatment of adult patients with acute bacterial skin and skin structure Discontinue infusion if signs of acute hypersensitivity occur. Carefully infections caused or suspected to be caused by susceptible isolates of monitor patients with known hypersensitivity to glycopeptides. (5.2) designated Gram-positive microorganisms. (1.1) • Infusion Related Reactions: Administer ORBACTIV over 3 hours to minimize infusion. Infusion related reactions have been reported with To reduce the development of drug-resistant bacteria and maintain the the glycopeptide class of antimicrobial agents, including oritavancin effectiveness of ORBACTIV and other antibacterial drugs, ORBACTIV products (e.g. ORBACTIV). Stopping or slowing the infusion may result should be used only to treat or prevent infections that are proven or strongly in cessation of these reactions. (5.3) suspected to be caused by bacteria. (1.2) • Clostridioides difficile-associated diarrhea: Evaluate patients if diarrhea occurs. (5.4) -----------------------DOSAGE AND ADMINISTRATION----------------------- • Concomitant warfarin use: ORBACTIV has been shown to artificially • There are two oritavancin products (ORBACTIV and KIMYRSA™, prolong PT/INR for up to 12 hours (5.1). Patients should be monitored another oritavancin product) that have differences in dose strength, for bleeding if concomitantly receiving ORBACTIV and warfarin. (5.5) duration of infusion and preparation instructions, including • Osteomyelitis: Institute appropriate alternate antibacterial therapy in reconstitution and dilution instructions and compatible diluents (2.1, patients with confirmed or suspected osteomyelitis. (5.6) 2.2, 2.3, 2.4) • Administer 1,200 mg of ORBACTIV as a single dose by intravenous -------------------------------ADVERSE REACTIONS------------------------------ infusion over 3 hours. (2.1, 5.3) The most common adverse reactions (≥3%) in patients treated with • Carefully follow the recommended dosage and dose preparation ORBACTIV were headache, nausea, vomiting, limb and subcutaneous instructions for ORBACTIV in the full prescribing information. (2.1, 2.2, abscesses, and diarrhea. (6.1) 2.3) To report SUSPECTED ADVERSE REACTIONS, contact Melinta ----------------------DOSAGE FORMS AND STRENGTHS--------------------- Therapeutics at 1-844-633-6568 or FDA at 1-800-FDA-1088 or For injection: 400 mg of lyophilized powder in a single-dose vial for www.fda.gov/medwatch. reconstitution. (3) See 17 for PATIENT COUNSELING INFORMATION ------------------------------CONTRAINDICATIONS------------------------------- • Use of intravenous unfractionated heparin sodium is contraindicated for Revised: 7/2021 120 hours (5 days) after ORBACTIV administration. (4.1, 5.1) • Known hypersensitivity to oritavancin products. (4.2, 5.2) FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 7.1 Effect of ORBACTIV on CYP Substrates 1.1 Acute Bacterial Skin and Skin Structure Infections 7.2 Drug-Laboratory Test Interactions 1.2 Usage 8 USE IN SPECIFIC POPULATIONS 2 DOSAGE AND ADMINISTRATION 8.1 Pregnancy 2.1 Dosage and Administration Overview 8.2 Lactation 2.2 Recommended Dosage 8.4 Pediatric Use 2.3 Preparation of ORBACTIV for Intravenous Infusion 8.5 Geriatric Use 2.4 Compatibility 8.6 Renal Impairment 2.5 Incompatibilities 8.7 Hepatic Impairment 3 DOSAGE FORMS AND STRENGTHS 10 OVERDOSAGE 4 CONTRAINDICATIONS 11 DESCRIPTION 4.1 Intravenous Unfractionated Heparin Sodium 12 CLINICAL PHARMACOLOGY 4.2 Hypersensitivity 12.1 Mechanism of Action 5 WARNINGS AND PRECAUTIONS 12.2 Pharmacodynamics 5.1 Coagulation Test Interference 12.3 Pharmacokinetics 5.2 Hypersensitivity 12.4 Microbiology 5.3 Infusion Related Reactions 13 NONCLINICAL TOXICOLOGY 5.4 Clostridioides difficile-associated Diarrhea 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.5 Potential Risk of Bleeding with Concomitant Use of Warfarin 14 CLINICAL STUDIES 5.6 Osteomyelitis 14.1 Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 5.7 Development of Drug Resistant Bacteria 16 HOW SUPPLIED/STORAGE AND HANDLING 6 ADVERSE REACTIONS 16.1 How Supplied/Storage 6.1 Clinical Trials Experience 17 PATIENT COUNSELING INFORMATION 6.2 Immunogenicity 7 DRUG INTERACTIONS *Sections or subsections omitted from the full prescribing information are not listed. 1 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Acute Bacterial Skin and Skin Structure Infections ORBACTIV® (oritavancin) is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only). 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORBACTIV and other antibacterial drugs, ORBACTIV should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 2 DOSAGE AND ADMINISTRATION 2.1 Dosage and Administration Overview There are two oritavancin products (ORBACTIV and KIMYRSA™, another oritavancin product) that: • Are supplied in different dose strengths of oritavancin [see Dosage Forms and Strengths (3)]. • Have different recommended durations of infusion [see Dosage and Administration (2.2)]. • Have different preparation instructions, including differences in reconstitution, dilution, and compatible diluents [see Dosage and Administration (2.3, 2.4)]. Carefully follow the recommended dosage and dose preparation instructions for ORBACTIV in this prescribing information (PI) [see Dosage and Administration (2.1, 2.2, 2.3, 2.4)]. Refer to the KIMYRSA prescribing information for relevant information of the other oritavancin product. 2 2.2 Recommended Dosage The recommended dosage of ORBACTIV is 1,200 mg administered as a single dose by intravenous infusion over 3 hours in patients 18 years and older [see Warnings and Precautions (5.3)]. 2.3 Preparation of ORBACTIV for Intravenous Infusion There are two oritavancin products (ORBACTIV and KIMYRSA, another oritavancin product) that have differences in dose strengths, duration of infusion, reconstitution and dilution instructions, and compatible diluents. Carefully follow the reconstitution, and dilution instructions with the appropriate compatible diluent for ORBACTIV specified in this prescribing information. Refer to the KIMYRSA prescribing information for relevant information of the other oritavancin product. ORBACTIV is intended for intravenous infusion, only after reconstitution and dilution. Three ORBACTIV 400 mg vials need to be reconstituted and diluted to prepare a single 1,200 mg intravenous dose. Reconstitution: Aseptic technique should be used to reconstitute three ORBACTIV 400 mg vials. • Add 40 mL of sterile water for injection (WFI) to reconstitute each vial to provide a 10 mg/mL solution per vial. • For each vial, gently swirl the contents to avoid foaming and ensure that all ORBACTIV powder is completely dissolved to form a reconstituted solution. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Each reconstituted vial should appear to be a clear, colorless to pale yellow solution, free of visible particles. Dilution: Use ONLY 5% dextrose in sterile water (D5W) for dilution to prepare the final intravenous solution for infusion. Do NOT use Normal Saline for dilution as it is incompatible with ORBACTIV and may cause precipitation of the drug. Since no preservative or bacteriostatic agent is present in ORBACTIV, aseptic technique must be used in preparing the final intravenous solution as follows: • Withdraw and discard 120 mL from a 1000 mL intravenous bag of D5W. • Withdraw 40 mL from each of the three reconstituted vials of ORBACTIV and add to D5W intravenous bag to bring the bag volume to 1000 mL. This yields a concentration of 1.2 mg/mL. Discard any unused portion of the reconstituted
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